FDA 510(k) Applications Received During May, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K001600 05/24/2000 CODA INCUBATOR CELLMATE INTL., INC. MICHAEL D CECCHI
K001486 05/12/2000 GENX CODA AIR PURIFICATION SYSTEM INTL., INC. MICHAEL D CECCHI
K001511 05/15/2000 O-LAS OPHTHALMIC PHOTODISRUPTOR A.R.C. LASER AG DANIEL HOEFER
K001382 05/02/2000 AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR AARON MEDICAL INDUSTRIES RICK KOZLOFF
K001547 05/18/2000 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP AB BIODISK ANNE BOLMSTROM
K001616 05/25/2000 MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE ABBOTT LABORATORIES CHRISTINE L LIONHOOD
K001510 05/15/2000 OS-2000 OPTICAL SONOGRAPHY SYSTEM ADVANCED DIAGNOSTICS, INC. STEVE HESLER
K001381 05/02/2000 CIDEX OPA SOLUTION ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K001567 05/19/2000 ADVANTAGE THC TEST ADVANTAGE DIAGNOSTICS CORP. JANIS FREESTONE
K001436 05/08/2000 AGILENT M2636A TELEMON MONITOR AGILENT TECHNOLOGIES, INC. DENISE HALEY
K001664 05/31/2000 COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K001776 05/31/2000 MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDSON
K001493 05/12/2000 DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 AIR FORCE, INC. PIERO POLICICCHIO
K001467 05/10/2000 DA VINCHI EMG/EP ISA1004EP AIRSEP CORP. PETER WEISENBORN
K001579 05/22/2000 IMPULSE SELECT AIRSEP CORP. JAMES A ALESSI
K001484 05/11/2000 CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 ALKO DIAGNOSTIC CORP. PATRICK CHIU
K001667 05/31/2000 RESOLVE SURGICAL O.R. TOWELS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K001520 05/16/2000 ALPHA OMEGA DUAL COOLER-HEATER ALPHA OMEGA, INC. RICHARD MARTIN
K001585 05/22/2000 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE AMERICAN BIOCURVE, INC. MARTIN DALSING
K001383 05/02/2000 SUPREMCAST "V" AMERICAN DENT-ALL, INC. VACHAKAN H KHOIE
K001401 05/03/2000 AMT THERAPEUTIC TABLE, MODEL 748AMT AMT MFG., INC. BILL DEACON
K001578 05/22/2000 ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K001420 05/05/2000 SLIDESCAN APPLIED IMAGING CORP. DIANE OATES
K001587 05/23/2000 19 GA PLASTIC REINFORCED EPIDURAL CATHETER ARROW INTL., INC. THOMAS D NICKEL
K001588 05/23/2000 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 ARTHROCARE CORP. BRUCE PROTHRO
K001480 05/11/2000 AURECAST 40 B AUREX SA (PTY) LTD. J. D DAVIS
K001478 05/11/2000 AURECAST SUPER INLAY AUREX SA (PTY) LTD. J. D DAVIS
K001477 05/11/2000 AURELUX Y 84 PREMIUM AUREX SA (PTY) LTD. J. D DAVIS
K001482 05/11/2000 AURENORM 75 KF AUREX SA (PTY) LTD. J. D DAVIS
K001481 05/11/2000 PALCERAM 49 AUREX SA (PTY) LTD. J. D DAVIS
K001479 05/11/2000 PALCERAM 53 AUREX SA (PTY) LTD. J. D DAVIS
K001632 05/26/2000 OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 AVL SCIENTIFIC CORP. RANDY BYRD
K001574 05/22/2000 DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 AXIS-SHIELD EILEEN A MCCAFFERTY
K001651 05/30/2000 BIO-RAD %CDT TIA AXIS-SHIELD BIOCHEMICALS, ASA RONALD G LEONARDI
K001571 05/22/2000 BAUMER FEMORAL HEAD BAUMER S.A. BRENO C FARAGO, JR.
K001539 05/17/2000 RENU MULTIPLUS MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K001422 05/05/2000 PSN HEMODIALYZER, MODELS PSN 170, PSN 210 BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K001364 05/01/2000 BD DIRECTIGEN FLU A+B BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MONICA GIGUERE
K001458 05/10/2000 SYNCHRON CONTROL BECKMAN COULTER, INC. LUCINDA STOCKERT
K001375 05/01/2000 ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) BEST MANUFACTURING COMPANY DAVID C YOUNG
K001373 05/01/2000 LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 BIO-RAD ELIZABETH PLATT
K001460 05/10/2000 VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 BIOMERIEUX, INC. JANET CONNOLLY
K001374 05/01/2000 PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K001660 05/31/2000 MALLORY HEAD MODULAR CALCAR BIOMET ORTHOPEDICS, INC. MICHELLE L MCKINLEY
K001580 05/22/2000 GROSS FEMORAL COMPONENT BIOMET, INC. TINA LAKIN
K001581 05/22/2000 LACTOSORB 5.0 MM WASHER BIOMET, INC. CAROL LAUSTER
K001376 05/01/2000 TI-MAX PROTRUSIO CAGE BIOMET, INC. TRACY J BICKEL
K001461 05/10/2000 TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET BIOMETRIX LTD. MIRIAM ABUTBUL
K001378 05/01/2000 BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 BIONX IMPLANTS, INC. TUIJA ANNALA
K001530 05/17/2000 THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. ERIC V HOHENSTEIN
K001390 05/02/2000 BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES BIOSENSE WEBSTER, INC. MARIA D OCHOA
K001640 05/08/2000 BIOSOFT RESIN BIOSOFT INTERNATIONAL CORP. ROY SHU
K001413 05/04/2000 ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 BIOTRONIK, INC. JON BRUMBAUGH
K001608 05/24/2000 BLAINE SCARCARE PATCH BLAINE LABS, INC. ROBERT BLAINE
K001391 05/02/2000 "BONUS" MECHANICAL WHEELCHAIR BONUS ENT. CORP. JEFF TEPERMEYSTER
K001596 05/23/2000 LIFERX BOWDENGS TECHNOLOGIES, LLC. JEFFERY BOWDEN
K001589 05/23/2000 CANDELA DYNAMIC COOLING DEVICE CANDELA CORP. JOAN M CLIFFORD
K001371 05/01/2000 CARDEON ASCENDING BALLOON CANNULA (ABC) CARDEON CORP. JANE BEGGS
K001462 05/10/2000 CARESIDE HEMOGLOBIN CARESIDE, INC. KENNETH B ASARCH
K001368 05/01/2000 PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER CARMEL PHARMA AB. KJELL ANDREASSON
K001662 05/31/2000 CHASE CARDIOVASCULAR PATCH CHASE MEDICAL, INC. DAVE HERNON
K001593 05/23/2000 MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL CHESTER LABS, INC. HOLLY SHERWOOD
K001509 05/15/2000 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K001598 05/24/2000 BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION COL-BAR LTD. JOHNATHAN S KAHAN
K001597 05/23/2000 CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX CONMED CORP. IRA D DUESLER, JR.
K001398 05/03/2000 REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K001631 05/26/2000 CORTEX METAMAX CORTEX BIOPHYSIK GMBH ART WARD
K001668 05/31/2000 GLOBAL SPINAL FIXATION SYSTEM D.K.M. CO.,LTD. ANDREW PAENG
K001647 05/30/2000 BN PROSPEC SYSTEM DADE BEHRING, INC. REBECCA S AYASH
K001645 05/30/2000 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 DADE BEHRING, INC. RADAMES RIESGO
K001463 05/10/2000 SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 DAVIS SCHOTTLANDER & DAVIS, LTD. CLARK SMITH
K001372 05/01/2000 E-Z LINK CROSS CONNECTOR DEPUY ACROMED KAREN F JURCZAK
K001470 05/11/2000 E-Z LINK CROSS CONNECTOR DEPUY ACROMED KAREN F JURCZAK
K001451 05/09/2000 MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K001534 05/17/2000 PINNACLE ACETABULAR SYSTEM DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K001523 05/16/2000 ULTIMA METAL-ON-METAL ACETABULAR CUP DEPUY ORTHOPAEDICS, INC. CHERYL HASTINGS
K001388 05/02/2000 DATA MASTER PERFUSION MONITORING SYSTEM DIDECO ROSINA ROBINSON
K001602 05/24/2000 DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) DIDECO S.P.A. BARRY SALL
K001629 05/26/2000 DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM DISETRONIC MEDICAL SYSTEMS AG LEE LEICHTER
K001488 05/12/2000 NARKOMED MRI , NM-MRI DRAEGER MEDICAL, INC. J TERESA DORREITY, JD
K001565 05/19/2000 STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB EDWARDS LIFESCIENCES, LLC. JOHN W SMITH
K001407 05/04/2000 SURGITRON IEC II ELLMAN INTL., INC. FRANK LIN
K001627 05/26/2000 TRIFIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K001437 05/08/2000 ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. ERIC KOEHLER
K001502 05/15/2000 AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO ERICH JAEGER GMBH LARRY MURDOCK
K001494 05/12/2000 MODIFICATION TO PROMPT L-POP ESPE DENTAL AG ANDREAS PETERMANN
K001625 05/17/2000 PRONOVA NONABSORBABLE SUTURE, USP ETHICON, INC. PETER M CECCHINI
K001496 05/15/2000 A.V. FISTULA NEEDLE EXELINT INTERNATIONAL CO. ARMAND HAMID
K001508 05/15/2000 LASERSKIN DRESSING FIDIA ADVANCED BIOPOLYMERS SRL PAOLO RAMPAZZO
K001527 05/16/2000 FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES FOTONA D.D. MOJCA VALJAVEC
K001518 05/16/2000 GRADIA GC AMERICA, INC. TERRY L JORITZ
K001624 05/26/2000 GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 GEBAUER CO. DENISE E SPELLMAN
K001434 05/08/2000 'COTTONY' II DACRON, "SILKY" II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) MARY E GRAY
K001440 05/08/2000 NEXTSTITCH CARDIOVASCULAR VALVE SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) MARY E GRAY
K001435 05/08/2000 VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. STACEY SIMON
K001686 05/18/2000 GALILEO VENTILATOR HAMILTON MEDICAL, INC. J. DAVID THOMPSON
K001669 05/31/2000 HANGER CRANIAL BAND HANGER ORTHOPEDIC GROUP, INC. JOSEPH MCTERNAN
K001490 05/12/2000 HARDYDISK CEFONICID, 30 MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K001489 05/12/2000 HARDYDISK CEFOPERAZONE, 75 MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K001487 05/12/2000 HARDYDISK CINOXACIN, 100 MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K001456 05/09/2000 CONSENSUS KNEE SYSTEM HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K001559 05/19/2000 CALCIUM SULFATE PELLETS HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K001385 05/02/2000 HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K001548 05/18/2000 MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K001419 05/05/2000 SOLAR SHOULDER OFFSET HUMERAL HEAD HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K001614 05/25/2000 STRYKER TRAUMA PELVIC SET HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001449 05/09/2000 TRIDENT ACETABULAR SHELLS: PS HOWMEDICA OSTEONICS CORP. TERRY S POWELL
K001448 05/09/2000 TRIDENT ACETABULAR SHELLS: PS-HA HOWMEDICA OSTEONICS CORP. TERRY S POWELL
K001653 05/30/2000 XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001615 05/25/2000 HUNTER SCIENTIFIC INJECTION PIPETTES HUNTER SCIENTIFIC LIMITED MARK RAWE
K001409 05/04/2000 GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER HYPERBARIC TECHNOLOGIES, INC. PAUL E DRYDEN
K001387 05/02/2000 I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-STAT CORP. PAUL VANDERWERF
K001550 05/18/2000 EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR IMATRON, INC. J. A CODUTO
K001471 05/11/2000 THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ IMPLEX CORP. JOHN A SCHALAGO
K001439 05/08/2000 ORTHOCEPH OC100 D INSTRUMENTARIUM CORP. TOMMI JOKINIEMI
K001521 05/16/2000 SOFTSENS INTEGRATED BIOSENSING TECHNOLOGIES RONALD LUICH
K001648 05/30/2000 INTRASTENT DOUBLESTRUT PARAMOUNT INTRATHERAPEUTICS, INC. CATHY YOHNK
K001666 05/31/2000 MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM INTUITIVE SURGICAL, INC. DAVID CASAL
K001410 05/04/2000 PHORESOR MODEL PM2000 IOMED, INC. W. TIM MILLER
K001522 05/16/2000 TRANSQ3 IOMED, INC. W. TIM MILLER
K001583 05/22/2000 ISLAND BIOSURGICAL BNS KIT #3 ISLAND BIOSURGICAL, LLC. HUNTER A MCKAY
K001469 05/10/2000 R&D PROJECT DW269#25 IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K001623 05/26/2000 SCULPTURE FLOW JENERIC/PENTRON, INC. ANNMARIE TENERO
K001445 05/08/2000 SMILIE PC JULIE ALLIANCE CLAUDE BERTHOIN
K001630 05/26/2000 KSEA BIPOLAR COAGULATING ELECTRODES KARL STORZ ENDOSCOPY KEVIN KENNAN
K001408 05/04/2000 KSEA VASCULAR FIBERSCOPES KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K001426 05/05/2000 KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K001423 05/05/2000 KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K001424 05/05/2000 KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K001655 05/31/2000 PERMLASTIC 2 KERR CORP. COLLEEN BOSWELL
K001557 05/19/2000 LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM KWAN HWA
K001447 05/09/2000 DULBECCO'S MODIFIED EAGLE MEDIUM ("DMEM") LIFE TECHNOLOGIES, INC. JONATHAN S KAHAN, ESQ.
K001441 05/08/2000 SATURN BLOOD GLUCOSE MONITORING TEST STRIP LIFESCAN, INC. MARY ELLEN HOLDEN
K001428 05/05/2000 OPTIMUM WETTING AND REWETTING DROP LOBOB LABORATORIES, INC. DANIEL J MANELLI
K001577 05/22/2000 OUTBACK CATHETER LUMEND, INC. PHIL HOPPER
K001609 05/24/2000 MALLARD AIR OXYGEN ACCUBLENDER MALLARD MEDICAL, INC. ROBERT PEARSON
K001584 05/22/2000 METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT MED VICE CONSULTING, INC. MARTIN DALSING
K001498 05/15/2000 THE FUGO BLADE MEDISURG LTD. RICHARD J FUGO
K001404 05/03/2000 GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON MEDNET LOCATOR, INC. JUDY CHANDLER
K001406 05/03/2000 HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES MEDNET LOCATOR, INC. JUDY CHANDLER
K001663 05/31/2000 FRONT-LOAD POLYPROPYLENE SYRINGE MEDRAD, INC. FRANK W PELC III
K001532 05/17/2000 DYNA-LOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE, PH.D.
K001620 05/25/2000 METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN METRO OPTICS OF AUSTIN, INC. MARTIN D ALSING
K001370 05/01/2000 ACCUSONIC PLUS, MODEL AP-100 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K001544 05/18/2000 VAGINAL APPLICATOR SHIELDED MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K001454 05/09/2000 SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014" DIAMETER, 145CM LENGTH, "SUPPORT") SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014" D MICRO THERAPEUTICS, INC. MARIBELLE AGUINALDO
K001545 05/18/2000 PIPET CURET MILEX PRODUCTS, INC. CARA FURLONG
K001546 05/18/2000 ALLON 2001 MTRE ADVANCED TECHNOLOGY LTD. PAUL DRYDEN
K001619 05/25/2000 MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) MULTISAFE SDN BHD ABD. HADI BIN HUSIN
K001497 05/15/2000 MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) MULTISAFE SDN BHD ABD. HADI BIN HUSIN
K001455 05/09/2000 ACCUWELL TSH, MODEL KAW-TSH-960 NEOMETRICS, INC. DAVID SCHWARTZ
K001562 05/19/2000 NEURO SCAN MEDICAL SYSTEMS A4000 NEURO SCAN LABS DAVID B JONES
K001564 05/19/2000 SCAN LT40 (40 CHANNELS) NEURO SCAN LABS DAVID B JONES
K001433 05/08/2000 CNS-9300 SERIES CENTRAL STATION NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K001465 05/10/2000 NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET NIPRO MEDICAL CORP. RICHARD D BLISS, JR.
K001369 05/01/2000 RESPIEVENTS, VERSION 4.2 NON-INVASIVE MONITORING SYSTEMS, INC. MARVIN A SACKNER, M.D.
K001464 05/10/2000 DISPOSABLE H-PE MICROKERATOME BLADES OASIS YVONNE FERNANDEZ
K001560 05/19/2000 ODONTOSURGE 3 ODONTO-WAVE JAMES DIEROFF
K001535 05/17/2000 ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION ORTHOTEC, L.L.C. DAVID W SCHLERF
K001516 05/16/2000 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K001612 05/25/2000 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K001386 05/02/2000 ACCUSET SENSOR, MODEL 2000 PELVICARE, INC. WALTER D WALLACH
K001529 05/17/2000 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K001397 05/03/2000 QUICKSCREEN PRO DRUG CUP, MODEL 9195X PHAMATECH CARL MONGIOVI
K001552 05/18/2000 TREPCHEK TREPONEMAL ANTIBODY EIA PHOENIX BIOTECH CORP. GARY LEHNUS
K001499 05/15/2000 PHORMAX EAGLE SCANNER SYSTEM PHORMAX CORP. SHEILA W PICKERING
K001377 05/01/2000 SPERMICIDAL LUBRICATED MALE LATEX CONDOM PLEASURE LATEX PRODUCTS SDN. BHD. LIM KOI-YONG
K001412 05/04/2000 PM 1800 CONSERVING DEVICE PRECISION MEDICAL, INC. CONLEY WALLACE
K001418 05/05/2000 ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S PROCERA SANDVIK, INC. MARTIN STERNER
K001576 05/22/2000 EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY PROSURG, INC. LEE BUI
K001392 05/03/2000 GLYCOSAL HBA1C TEST PROVALIS DIAGNOSTICS LTD. TOM TSAKERIS
K001646 05/30/2000 PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION PURITAN BENNETT CORP. MARY E FUNK
K001485 05/12/2000 HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES PWA INDUSTRIES SDN. BHD. AZHARSYAH M YASSIN
K001475 05/11/2000 HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR PWA INDUSTRIES SDN. BHD. AZHARSYAH M YASSIN
K001492 05/12/2000 QUINTON Q-STRESS, MODEL 000483 QUINTON, INC. DAVID HIMES
K001414 05/04/2000 KWIKKMODEL R-DENTAL DENTALERZEUGNISSE GMBH ANDREAS SPRAFKE
K001599 05/24/2000 ACTI-FLEX IV ADMINISTRATION SET R-GROUP INTL. KERRY ANNE KAHN
K001431 05/08/2000 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) RADIONICS, INC. KEVIN J O'CONNELL
K001607 05/24/2000 REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) REPROMEDIX CORP. HAN-SOO KIM
K001603 05/24/2000 REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) REPROMEDIX CORP. HAN-SOO KIM
K001606 05/24/2000 REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) REPROMEDIX CORP. HAN-SOO KIM
K001468 05/10/2000 ELECSYS CA 15-3 TEST SYSTEM ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K001421 05/05/2000 ONTRAK TESTCUP 501, MODEL 3016633 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K001417 05/05/2000 ONTRAK TESTCUP 502, MODEL 3016641 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K001641 05/30/2000 TAMPONS ROSTAM LTD. ROBERT J STAAB
K001411 05/04/2000 WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 SCANTIBODIES LABORATORY, INC. RICHARD LENART
K001429 05/05/2000 MODIFICATION TO ACCUDEXA BONE DENSITOMETER SCHICK TECHNOLOGIES, INC. DANIEL MICHAELI
K001446 05/08/2000 LIGHT-CURED ORTHODONTIC BAND CEMENT SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K001563 05/19/2000 SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET SCION CARDIOVASCULAR, INC. DAVID B JONES
K001427 05/05/2000 MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. CAROL A ADILETTO
K001432 05/08/2000 DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PM PLASTICS ENT. CO., LTD. CHANG T SUN
K001549 05/18/2000 MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K001601 05/24/2000 DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. PETER WANG
K001611 05/25/2000 DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. PETER WANG
K001637 05/30/2000 DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR SHEEN MORE ENT. CO., LTD. KEN HUANG
K001517 05/16/2000 SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES SHIMADZU CORP. MICHAEL FISHBACK
K001400 05/03/2000 ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JUDI HOFFMAN
K001569 05/19/2000 INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K001403 05/03/2000 SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K001555 05/18/2000 SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 SIMS PORTEX LTD. STEVEN M OGILVIE
K001507 05/15/2000 MICROPERFORATION INSTRUMENT SMITH & NEPHEW, INC. NICHOLAS CONDAKES
K001466 05/10/2000 VOCOM SILICONE SYSTEM SMITH & NEPHEW, INC. ALICIA E FARAGE
K001438 05/08/2000 SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR SOMNUS MEDICAL TECHNOLOGIES, INC. STEVEN J OJALA, PH.D
K001604 05/24/2000 DANA DIABECARE SOOIL DEVELOPMENT CO., LTD. CYNTHIA J NOLTE
K001476 05/11/2000 TORQUE INSTRUMENT, MODEL 8500 SPINALIGHT, INC. T. A COX
K001528 05/17/2000 PC FLOW + SPIROMETRICS MEDICAL EQUIPMENT CO. JAMES R VEALE
K001367 05/01/2000 FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX ST. JUDE MEDICAL, INC. PAUL CORNELISON
K001649 05/30/2000 STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 STERITEC PRODUCTS, INC. LINDA NELSON
K001444 05/08/2000 STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 STERITEC PRODUCTS, INC. LINDA NELSON
K001443 05/08/2000 SUGAR CHEX ONE STRECK LABORATORIES, INC. PAUL KITTELSON
K001536 05/17/2000 INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K001491 05/12/2000 QUICKIE 2 POWER ASSIST WHEELCHAIR SUNRISE MEDICAL, INC. BRYAN DANNETTELL
K001442 05/08/2000 ESU HANDSWITCHING PENCIL SURGEX, INC. DANIEL J MANELLI
K001594 05/23/2000 3.5 MM LAPAROSCOPE (LG100, LG103) SURGICAL IMAGE LABORATORIES, INC. ZOLTAN BALAZS
K001642 05/30/2000 INSIGHT IMAGE GUIDED SURGICAL SYSTEM SURGICAL INSIGHTS, INC. JON T LEA
K001572 05/22/2000 NEOLUS NEEDLE TERUMO EUROPE N.V. M J AERTS
K001474 05/11/2000 TERUMO U-100 INSULIN SYRING TERUMO MEDICAL CORP. SANDI HARTKA
K001636 05/30/2000 C-REACTIVE PROTEIN ANTISERUM KIT THE BINDING SITE, LTD. JAY H GELLER
K001556 05/18/2000 HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY THE BINDING SITE, LTD. JAY H GELLER
K001515 05/16/2000 PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 THE PROMETHEUS GROUP RICHARD HORTON
K001524 05/16/2000 FORMA SCIENTIFIC DIRECT HEAT INCUBATORS THERMOQUEST CORP. RICHARD L MILLER
K001638 05/30/2000 O-RING PROSTHETIC ATTACHMENT TITAN IMPLANTS LYNETTE L HOWARD
K001592 05/23/2000 ECHOCOM, IMAGECOM, DOKUCOM TOMTEC IMAGING SYSTEMS, GMBH FLORIAN EISENBERGER
K001573 05/22/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K001558 05/19/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K001525 05/16/2000 CAPTIA SYPHILIS-G ELISA TEST SYSTEM TRINITY BIOTECH, PLC WAYNE KVETKOSKY
K001634 05/26/2000 CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 TZ MEDICAL, INC. BYRON ZAHLER
K001450 05/08/2000 AUTO SUTURE MICRO SURGICLIP CLIP APPLIER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHRISTOPHER A GRAHAM
K001590 05/17/2000 DND 101 UROGYN LTD. KENNETH T BURCK
K001582 05/22/2000 LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE USA INSTRUMENTS, INC. RONY THOMAS
K001643 05/30/2000 VARIS 1.4G VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K001633 05/26/2000 LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 VASCA, INC. DOUGLAS E FERGUSON
K001621 05/26/2000 DARDIK CAROTID SHUNT VASCUTECH, INC. TRENT G KAMKE
K001541 05/17/2000 MINICAM VIDEO DENTAL CONCEPTS, INC. CLAUDE BERTHOIN
K001553 05/18/2000 BREAS PV 100 CPAP SYSTEM VITAL SIGNS, INC. ANTHONY P MARTINO
K001430 05/05/2000 RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K001533 05/17/2000 SURGIFLATOR-40 W.O.M. GMHB MICHAEL MCGRAIL
K001543 05/17/2000 BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 WELCH ALLYN, INC. ZORAN PSENICNIK
K001519 05/16/2000 ACTICOAT 7 DRESSING WESTAIM BIOMEDICAL, INC. STEVE CHARTIER
K001613 05/25/2000 COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) WRP ASIA PACIFIC SDN. BHD. YUE WHA CHOW
K001393 05/03/2000 THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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